SourceMark

Basic Information

• Brand Name: SourceMark
• Primary DI: 00813799003608
• Version / Model: SLMIL20
• Company Name: SOURCEMARK, LLC.
• Labeler DUNS: 121225812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-04
• Public Version: 1
• Public Version Date: 2020-12-14
• Public Version Status: New
• Public Device Record Key: ca6ef7da-5935-4105-922d-483394c82c10

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCW	Laryngoscope, Rigid	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36645	Flexible fibreoptic laryngoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the larynx. It is inserted into the body through the mouth during laryngoscopy. Anatomical images are transmitted through a fibreoptic bundle to the user for direct visualization (i.e., non-video). This device is commonly used to evaluate or operate on laryngeal strictures, foreign bodies, or neoplasms; it is not intended for intubation of an artificial airway. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10813799003612	GS1	Box	10	In Commercial Distribution
Primary	00813799003608	GS1